SPHERONIZATION

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SPHERONIZATION

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By: nihalhalawa5 (11 month(s) ago)

???????????????????

By: nihalhalawa5 (11 month(s) ago)

?????????????

By: nihalhalawa5 (11 month(s) ago)

and my display name is : nihal halawa

By: nihalhalawa5 (11 month(s) ago)

my e-mail id is: dr_nihalh@hotmail.com is that what u need? by the way i need the cosmetics presentation and not the spheronization :)

By: sumit_191 (12 month(s) ago)

nihalhalawa5@ you can give me your email id. so that i send u my presentation for educational purpose.

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SPHERONIZATION:

SPHERONIZATION 1 SUMIT KUMAR (M.PHARM) QUALITY ASSURANCE I.S.F COLLEGE OF PHARMACY, MOGA (PUNJAB )

CONTENTS :

CONTENTS INTRODUCTION ADVANTAGES EXCIPIENTS EXTRUSION SPHERONIZTION PROCESS VARIABLES EVALUATION 2

INTRODUCTION:

INTRODUCTION 3

ADVANTAGES:

ADVANTAGES Flexibility in development of oral dosage forms. Manufacture of modified release solid dose formulations by applying different coating materials. The easy formulation and mixing of otherwise incompatible formulations. These have low surface to volume ratio that enables uniform film coating. Improved flow characteristics. 4

ADVANTAGES (cont.):

ADVANTAGES (cont.) To offer dust free packaging. Density increase - Both the true and the bulk density of granules . Hardness and friability - Spheronisation increases the hardness and reduces the friability . Reduce the amount of fines generated during handling or transportation. Improved product appearance. 5

EXTRUSION-SPHERONISATION PROCESS:

EXTRUSION-SPHERONISATION PROCESS Preparation of wet mass (Mixing) Shaping the wet mass into cylinders (Extrusion) Breaking up the extrudate and rounding of the particles into spheres ( Spheronisation ) Drying of the pellets 6

COMMONLY USED EXCIPIENTS :

COMMONLY USED EXCIPIENTS Fillers MCC, Dibasic calcium phosphate, Ca sulfate, Lactose, Mannitol , Starch, Sucrose Binders Gelatin, HPMC, HPC, MC, PVP, Sucrose, Starch Lubricants Ca and Mg stearate , Glycerin, Hydrogenated veg.oil, PEG, Propylene glycol Disintegrants Crospovidone , Sodium starch glycolate , Alginates Surfactants Polysorbates , SLS Spheronisation enhancers MCC, Sod. CMC Glidants Colloidal silicon dioxide, Mg stearate , Starch, Talc Release modifier EC, Carnauba wax, Shellac 7

EXTRUSION EQUIPMENTS:

EXTRUSION EQUIPMENTS Screw-feed extruders(axial or end –plate, dome and radial) Gravity-feed extruders(cylindrical roll, gear roll, radial) Piston-feed extruders(ram) 8

SPHERONIZATION:

SPHERONIZATION During the spheronization process, the cylinders obtained from extrusion dumped onto the friction plate of the spheronizer where the extrudate is broken up into small cylinders with a length equal to their diameter. Spheres with a diameter ranging from 0.5 to 10 mm can be obtaine . 9

Spheronization The wet extrudates are placed in a spheronizer where a gridded, fast spinning disc, breaks them into smaller particles and rounds them to form spheres. Stages of spheronization: Extrudates After 5 seconds After 15 seconds After 120 seconds:

Spheronization T he wet extrudates are placed in a spheronizer where a gridded, fast spinning disc, breaks them into smaller particles and rounds them to form spheres. Stages of spheronization : Extrudates After 5 seconds After 15 seconds After 120 seconds 10

SPHERONIZATION:

SPHERONIZATION The machine consists of a round disc with vertical shaft, spinning at high speed at the bottom of a cylindrical chamber. The cylindrical chamber is called “ bowl ” and the spinning disc is called “ friction plate ”. This friction plate has often a groove pattern to increase the friction with the product. 11

Mech. proposed for the formation of spheres :

Mech. proposed for the formation of spheres 12

mech. proposed for the formation of spheres (cont.):

mech. proposed for the formation of spheres (cont.) 13

Types of friction plates of a spheronizer:

Types of friction plates of a spheronizer Dimensions of the surface protuberances of (A) cross-hatch and (B) teardrop-studded rotating frictional plates. 14

Details of Equipment Used for Spheronization of Extrudates :

Details of Equipment Used for Spheronization of Extrudates PROCESS SPHERONIZING EQUIPMENT DIAMETER OF FRICTION PLATE(mm) TEXTURE OF FRICTION PLATE ESC Spheronizer [ S 320,GEA-Nitro, East- leigh , UK] 320 Cross- hatch design plate [grooves with edges well defined & reasonably sharp EST Rotary processor[MP 1, Aeromatic -fielder, Eastleigh , UK 275 Teaardrop -studded plate [stud height, 2.75 mm, edges rounded 15

EQUIPMENTS SPHERONIZER 250:-:

EQUIPMENTS SPHERONIZER 250 :- 16

SPHERONIZER 380 :

SPHERONIZER 380 17

SPHERONIZER 500 :

SPHERONIZER 500 18

SPHERONIZER 700 :

SPHERONIZER 700 19

PROCESS VARIABLES:

PROCESS VARIABLES STARTING MATERIAL :-physical nature of starting material influence particle size,hardness and sphericity as well as release rate of the included drug. For eg :-pellets prepared with 3 types of mcc i.e microcrystalline cellulose from different manufacturers featured in size and roundness when processed under same conditions.The physical properties of two types of commercial mcc showed differences during the step of moistening thereby affecting the particle size and hardness of pellets obtained 20

PowerPoint Presentation:

GRANULATION LIQUID :-The most commonly used granulating liquid is water, although in some case the use of alcohol or water- alcohol mixture has also been reported.Increasing the water content of the granulating liquid leads to an increase in hardness of pellets. EXTRUDER :-An axial screw extruder produces a denser material than a radial screw extruder. The latter has higher out put but also produces a greater rise in the temprature of the mass during the process. 21

PowerPoint Presentation:

EXTRUSION TEMPERATURE : A rise in temperature during the extrusion cycle could cause some of the liquid to evaporate from the granules. In turn, that may leads to a difference in quality of the extrudate produced at the beginning of the batch vs. end. Extrusion temperature control is especially important when processing a thermolabile formulation. 22

PowerPoint Presentation:

SPHERONIZER SPEED :-The speed of the spheronizer plate should be kept constant during the whole process. It has been found that speed affect the size, hardness, sphericity & density of the pellets. For eg :- higher speed Give higher sphericity , lower friability, smooth surface & higher crushing strength 23

PowerPoint Presentation:

SPHERONIZATION TIME & LOAD :-High spheronization time results in pellet with narrow size distribution, higher sphericity , lower friability, smooth surface, reduced pore vol. & higher tensile strength. LOAD :-with an increase in spheronizer load, size of the pellet decreases while density inc. DISC GROOVE GEOMETRY :- Sq. cross-hatched design is most commomnly used. PRODUCT PARAMETER :-The particles must be plastic enough to allow deformation during collision, but also must be strong enough to withstand collision with the disc, other particles & the spheronizer wall w.o.t backing up. 24

PowerPoint Presentation:

RETENTION TIME :-Typical spheroniztion retention time, necessary to obtain spheres is from 3 to 8 min. OTHER FACTORS :- Binder = It can be use to inc. the strength of granules & reduce the amount of dust. Lubricant = It will inc. the plasticity but also inc. the amt. of fine dust. Moisture content for spheronization is slightly less than for extrusion. 25

EVALUATION :

EVALUATION Size analysis : Size distribution of the pellets in any batch should be as narrow a possible. The size of pellets can be expressed by using parameters such as – arithmetic mean diameter, geometric mean diameter, mean particle width and length. The various factors affecting particle size are- Extrusion screen opening Spheronisation time Spheronisation speed Drying technique and temperature Moisture content Binder type and conc. 26

EVALUATION(cont.):

EVALUATION(cont.) Sphericity : Aspect ratio – It is the ratio of longest to the shortest dimension of the particle. Its value is taken as 1 for circle, square . A shape factor eR was developed based on deviation of shape from a circle towards an ellipse and surface irregularities eR = 2 П r e √1-( b/l ) 2 Pm Where r e = Average radius of particle Pm = measured perimeter of the particle l = length of particle b = breadth of particle 27

Sphericity (cont.):

Sphericity (cont.) Koo and Heng tech to describe shape of pellet involves following formulae   Roundness = area П x (max. radius) 2 Elongation = max. radius min. radius Rectangle = area 4 x max. Radius x min. radius 28

EVALUATION(cont.):

EVALUATION(cont.) Friability and granule strength :- They affect changes in particle size distribution of granules. They affect compressibility into cohesive tablets. The granule strength can be measured by using a particle hardness tester by the equation : St = 0.7P( Π d 2 /4) Where St = Granule strength P = Strength when the granule was broken d = Dia. of the granule 29

EVALUATION(cont.) Density::

EVALUATION(cont.) Density: Bulk density is the indicative of the packing properties and is greatly influenced by the dia. of the spherical granules. The tapped density of pellets can be measured by using an automated tapper. Density can be measured by – Solvent displacement method at low pressures. Hausner ratio (HR) – It is the quotient of the tapped density to its bulk density. HR = ρ t/ ρ b Where ρ t - tapped density ρ b - bulk density A high Hausner ratio indicates increased cohesion between particles and therefore poorer flow 30

EVALUATION(cont.) Porosity:-:

EVALUATION(cont.) Porosity:- It is a measure of void spaces in a material and can be calculated by using tech. such as- density, gas adsorption, water displacement and porosimetry . Pore size measurement i.e pore diameter and volume can be done by gas adsorption and mercury porosimetry . Mercury porosimetry is based on intrusion of mercury into the pores of a solid sample and is quantified using Washburn eqn. Pr = -2 γ Cos θ Where P = pressure (Psig) r = radius of pore ( μ m) θ = contact angle of mercury γ = surface tension of mercury (dynes/cm) 31

Flow properties:

Flow properties Measurement of the repose angle Shear strength determination Flow-rate measurements. There are many fundamental properties of solid particles that influence their flow properties like particle size, particle size distribution, particle shape, surface texture or roughness, residual surface energy and surface area. High polysorbate80 conc. imparted tackiness to the granules producing a large angle of repose and reduced flow velocity. Increase in water content to the granulations, decreased the flow rate. 32

REFERENCES:

REFERENCES www.caleva.co.uk Spheronization.com info@glattair.com The science of dosage form design audited by M.E.Aulton 33

PowerPoint Presentation:

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